Collins McNicholas

Senior Manufacturing Engineer

The Senior Manufacturing Engineer applies knowledge of technical principles and systems/procedures to optimize manufacturing processes.

Job Functions:

  • Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
  • Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
  • Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
  • Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
  • Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

Required Education & Skills:

  • A Bachelor’s degree in Mechanical, Biomedical, or equivalent engineering degree is required.
  • Minimum of 4 years’ experience in Quality or Manufacturing is required
  • Proven expertise in usage of MS Office Suite; CAD experience preferred
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
  • Basic understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Substantial understanding of processes and equipment used in assigned work
  • Good leadership skills and ability to influence change
  • Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
  • Knowledge of applicable FDA regulations for medical device industry
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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